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Complementary and Alternative Medicine

Effectiveness of Mindfulness Meditation vs Headache Education for Adults With MigraineA Randomized Clinical Trial

Educational Objective: To determine if mindfulness-based stress reduction improves migraine outcomes and affective/cognitive processes compared with headache education.
1 Credit CME
JAMA Internal Medicine
March 1, 2021
Original Investigation
Rebecca Erwin Wells, MD, MPH1;
Nathaniel O’Connell, PhD2;
Charles R. Pierce, MS1;
Paige Estave3;
Donald B. Penzien, PhD1,4,5;
Elizabeth Loder, MD, MPH6;
Fadel Zeidan, PhD7;
Timothy T. Houle, PhD8
Author Affiliations
  • 1Comprehensive Headache Program, Department of Neurology, Wake Forest Baptist Health, Winston-Salem, North Carolina
  • 2Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest Baptist Health, Winston-Salem, North Carolina
  • 3Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina
  • 4Department of Psychiatry and Behavioral Medicine, Wake Forest Baptist Health, Winston-Salem, North Carolina
  • 5Department of Epidemiology & Prevention, Division of Public Health Sciences, Wake Forest Baptist Health, Winston-Salem, North Carolina
  • 6Department of Neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 7Department of Anesthesiology, University of California, San Diego, La Jolla
  • 8Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston
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Key Points

Question  Does mindfulness-based stress reduction (MBSR) improve migraine outcomes and affective/cognitive processes compared with headache education?

Findings  In this randomized clinical trial of 89 adults who experienced between 4 and 20 migraine days per month, standardized training in mindfulness and yoga through MBSR did not improve migraine frequency more than headache education about migraine, as both groups had similar decreases.

Meaning  Mindfulness meditation may help treat the total burden of migraine, although a larger, more definitive study is needed to further investigate these results to understand the association of mindfulness with migraine outcomes.

Abstract

Importance  Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or adverse effects. Mindfulness-based stress reduction (MBSR) may provide benefit.

Objective  To determine if MBSR improves migraine outcomes and affective/cognitive processes compared with headache education.

Design, Setting, and Participants  This randomized clinical trial of MBSR vs headache education included 89 adults who experienced between 4 and 20 migraine days per month. There was blinding of participants (to active vs comparator group assignments) and principal investigators/data analysts (to group assignment).

Interventions  Participants underwent MBSR (standardized training in mindfulness/yoga) or headache education (migraine information) delivered in groups that met for 2 hours each week for 8 weeks.

Main Outcomes and Measures  The primary outcome was change in migraine day frequency (baseline to 12 weeks). Secondary outcomes were changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, and 36 weeks).

Results  Most participants were female (n = 82, 92%), with a mean (SD) age of 43.9 (13.0) years, and had a mean (SD) of 7.3 (2.7) migraine days per month and high disability (Headache Impact Test-6: 63.5 [5.7]), attended class (median attendance, 7 of 8 classes), and followed up through 36 weeks (33 of 45 [73%] of the MBSR group and 32 of 44 [73%] of the headache education group). Participants in both groups had fewer migraine days at 12 weeks (MBSR: −1.6 migraine days per month; 95% CI, −0.7 to −2.5; headache education: −2.0 migraine days per month; 95% CI, −1.1 to −2.9), without group differences (P = .50). Compared with those who participated in headache education, those who participated in MBSR had improvements from baseline at all follow-up time points (reported in terms of point estimates of effect differences between groups) on measures of disability (5.92; 95% CI, 2.8-9.0; P < .001), quality of life (5.1; 95% CI, 1.2-8.9; P = .01), self-efficacy (8.2; 95% CI, 0.3-16.1; P = .04), pain catastrophizing (5.8; 95% CI, 2.9-8.8; P < .001), depression scores (1.6; 95% CI, 0.4-2.7; P = .008), and decreased experimentally induced pain intensity and unpleasantness (MBSR group: 36.3% [95% CI, 12.3% to 60.3%] decrease in intensity and 30.4% [95% CI, 9.9% to 49.4%] decrease in unpleasantness; headache education group: 13.5% [95% CI, −9.9% to 36.8%] increase in intensity and an 11.2% [95% CI, −8.9% to 31.2%] increase in unpleasantness; P = .004 for intensity and .005 for unpleasantness, at 36 weeks). One reported adverse event was deemed unrelated to study protocol.

Conclusions and Relevance  Mindfulness-based stress reduction did not improve migraine frequency more than headache education, as both groups had similar decreases; however, MBSR improved disability, quality of life, self-efficacy, pain catastrophizing, and depression out to 36 weeks, with decreased experimentally induced pain suggesting a potential shift in pain appraisal. In conclusion, MBSR may help treat total migraine burden, but a larger, more definitive study is needed to further investigate these results.

Trial Registration  ClinicalTrials.gov Identifier: NCT02695498

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Complementary and Alternative Medicine Headache Neurology
Article Information

Accepted for Publication: October 2, 2020.

Published Online: December 14, 2020. doi:10.1001/jamainternmed.2020.7090

Corresponding Author: Rebecca Erwin Wells, MD, MPH, Comprehensive Headache Program, Department of Neurology, Wake Forest Baptist Health, Medical Center Blvd, Janeway Tower, Winston-Salem, NC 27157 (rewells@wakehealth.edu).

Author Contributions: Dr Wells had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Wells, Zeidan, Penzien, Loder, Houle.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Wells, Zeidan, Pierce, Penzien, Loder, O’Connell, Houle.

Critical revision of the manuscript for important intellectual content: Wells, Zeidan, Estave, Penzien, Loder, O’Connell, Houle.

Statistical analysis: Wells, Zeidan, O’Connell, Houle.

Obtained funding: Wells, Zeidan.

Administrative, technical, or material support: Wells, Zeidan, Pierce, Penzien.

Supervision: Wells, Zeidan, Penzien, Loder, Houle.

Conflict of Interest Disclosures: Drs Wells and Zeidan reported grants from the National Institutes of Health during the conduct of the study. Dr Houle reported personal fees from GlaxoSmithKline, Eli Lilly, and StatReviewer outside the submitted work. No other disclosures were reported.

Funding/Support: This study was funded by an American Pain Society Grant from the Sharon S. Keller Chronic Pain Research Program, as well as the National Center for Complementary and Integrative Health K23AT008406, R21-AT010352, K99-R00 AT008238, and R01AT009693.

Role of the Funder/Sponsor: The American Pain Society and the National Center for Complementary and Integrative Health had no role in the collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Data Sharing Statement: See Supplement 3.

Additional Contributions: This study was an extraordinary team effort, and we appreciate all the support and help of all those involved. We appreciate all the participants in this study. We are thankful for all the health care professionals who referred patients into the study, including but not limited to Lauren Strauss, DO; Laura Granetzke, MSN; Vanessa Baute Penry, MD; Cormac O’Donovan, MD; Starla Wise, DO; Sandhya Kumar, MD; Nada El-Husseini, MD, MHS; Jane Boggs, MD; Jessica Tate, MD; Heidi Munger Clary, MD, MPH; and Clark W. Pinyan, MD, MPH. We are appreciative of our MBSR instructor, Ann McCarty, PA, and our headache education instructor, Megan Irby, PhD, who were compensated for their roles in this study. We are grateful for the support of the Wake Forest Baptist Department of Neurology, Allison Brashear, MD, Charles Tegeler, MD, Kevin Shuping, and the Comprehensive Headache Program. We are grateful for the help from the Maya Angelou Center for Health Equity for help in diverse recruitment and study participation. Special thanks to Claudia Nielson, Steve Thomas, and the Creative Communications Design Team and Sarah Diamont with Marketing at Wake Forest Baptist Health. We appreciate the support of Brian Moore and the Wake Forest Institutional Review Board and Data and Safety Monitoring Board. We appreciate the support from the Wake Forest Clinical Translational Science Institute (CTSI), the Clinical Research Unit staff and support, and the Research Coordinator Pool, funded by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR001420, who helped support the significant research coordinator support from Emily Ansusinha, Elizabeth Crenshaw, Carolyn Hedrick, Sandra Norona, Nancy Lawlor, and Brittany Briceno. We are so thankful for the additional research coordination support from Imani Randolph, MA, Jason Collier, Grace Posey, MS, and Georgeta Lester, who were compensated for their efforts. This study would not have been completed without the tremendous support of a multitude of volunteer students, including Nicole Rojas, Hudaisa Fatima, Obiageli Nwamu, MA, Vinish Kumar, Rosalia Arnolda, Paige Brabant, Danika Berman, Nicholas Contillo, Flora Chang, Geena George, Easton Howard, Caitlyn Margol, Mariam Shakir, Reid Anderson, Camden Nelson, Carson DeLong, Summerlyn Beeghly, and Anissa Berger. Several of the students received American Academy of Neurology Neuroscience is Rewarding Internship scholarship awards for their work on this project, including Nicholas Contillo, Flora Chang, Caitlyn Margo, Easton Howard, Geena George, Reid Anderson, Mariam Shakir, Anissa Berger, and Summerlyn Beeghly.

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